"During the second quarter, we reached a significant milestone by recording our first IRRAflow revenue in the United States (US). The US is the world's largest market for neurosurgical procedures, and with the ongoing CE Mark recertification process, we have focused much of our team's resources toward supporting a successful early market introduction in the US."

Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS
 

Second quarter, April - June 2019

• Net revenue totaled SEK 1.1 million (0.1)
• Operating loss (EBIT) amounted to SEK -40.7 million (-32.1)
• Loss after tax totaled SEK -40.2 million (-29.1)
• Earnings per share before and after dilution amounted to SEK -1.55 (-1.23)

Period January - June 2019

• Net revenue totaled SEK 1.1 million (6.0)
• Operating loss (EBIT) amounted to SEK -79.8 million (-53.2)
• Loss after tax totaled SEK -78.9 million (-47.0)
• Earnings per share before and after dilution amounted to SEK -3.15 (-1.99)

Important events during the quarter

• Acquisition of complementary medical device technology

In April, IRRAS entered into an agreement with the Alfred E. Mann Institute for Biomedical Engineering at the University of Southern California (AMI-USC) to acquire assets and intellectual property from DermaPort Inc. 

• Position strengthened through acquisition of proprietary assets 

IRRAS strengthened its position as a market leader by acquiring the assets of InnerSpace Neuro Solutions, including four US FDA-cleared products that complement IRRAflow.

• IRRAflow wins regulatory approval in Israel and Costa Rica

In June, IRRAS received regulatory approval in Israel and Costa Rica for the company's flagship product, IRRAflow. 

• Update on CE Mark re-certification of IRRAflow

In April, IRRAS announced that the company had received a response from G-MED, its designated European Notified Body, that requested clarifications and additional information regarding the company's CE Mark re-certification of the IRRAflow catheter. 

• New Board member

The Annual General Meeting in May elected Catherine Gilmore-Lawless as a new Board member of IRRAS. Gilmore-Lawless is an American citizen and has 30 years of experience in the neuroscience sector.

• Changes in management group

In June, IRRAS announced that the company's CFO, Fredrik Alpsten, would be leaving the company and that Sabina Berlin had been promoted to the position of CFO. The company also announced that Lance Boling, VP Product Development, would revert to a consultant position for the company.

• Raising capital through directed share issue

In May, the company completed a directed share issue and net proceeds to the company amounted to SEK 97.3 million. The subscribers in the issue were a number of Swedish and international institutional investors.

Important events after the end of the quarter

• No important events have taken place after the end of the quarter.

 

About IRRAS

IRRAS AB (Nasdaq First North Premier: IRRAS) is a global healthcare company focused on delivering innovative medical technologies to our customers and their patients. IRRAS designs, develops and commercializes products that improve patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methods in neurocritical care. IRRAS markets and sells its products to hospitals worldwide through its direct sales organizations in the U.S. and select European countries and a network of distribution partners in other markets.  

IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit www.irras.com. 

IRRAS AB (publ) is listed on Nasdaq First North Premier. Redeye AB is certified adviser of the company with email certifiedadviser@redeye.se orphone 08-121 576 90.

For more information, please contact:

USA
Kleanthis G. Xanthopoulos, Ph.D.
President and CEO
info@irras.com  

Europa
Sabina Berlin
CFO
+46 73 951 95 02
sabina.berlin@irras.com
 

This document is considered information that IRRAS is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person above, on August 29, 2019 at 8:00 a.m. (CET).